GEN News Highlights

PDUFA V Supporters Try to Sell Congress on Job, Innovation Potential

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FDA Commissioner Margaret A. Hamburg, M.D., joined several biopharma leaders and supporters Wednesday in pressing Congress for quick approval of the fifth authorization of the Prescription Drug User Fee Act ( PDUFA V). They tied the measure as much to its benefits to industry and the broader economy as to the agency’s goals.

Testifying before the House Committee on Energy and Commerce’s Subcommittee on Health, Dr. Hamburg said FDA would continue the industry-friendlier approach reflected in both several recent policy actions and the agency’s self-description as America’s Innovation Agency: “It is critical to our public health mission that we work with industry and other stakeholders to take steps to reduce uncertainty and increase the success of all phases of drug development.”

Under PDUFA V, she noted, FDA will hold a public meeting to discuss potential strategies to facilitate scientific exchanges on biomarker issues between the agency and drug developers. Dr. Hamburg also stated: FDA’s struggle to meet PDUFA review timeframes soon after enactment of the Food and Drug Administration Amendments Act of 2007, she said, reflected drug developers increasingly going overseas for clinical trials and drug manufacturing as much as the law’s increased demands on the agency.

“While foreign sites can play an important role in enabling access to new drugs, the need to travel much farther to conduct pre-approval inspections for clinical trials and manufacturing sites overseas has created additional challenges for completion of FDA’s review within the existing PDUFA review performance goals,” Dr. Hamburg said.

She also used her testimony to continue trumpeting FDA successes both last year and during the two decades since PDUFA’s first authorization. In 2011, she said, all but one of the 35 new medicines approved by FDA met PDUFA targets for review timeframes, while 24 of the 35 were approved by FDA ahead of other global regulatory agencies. And since 1992, she added, the time required for the FDA approval phase of new drug development has been halved from an average two years to 1.1 years.

While the hearing was titled: “Reauthorization of PDUFA: What it means for Jobs, Innovation and Patients,” it was left to others to make more direct connections between FDA’s performance and its effect on jobs and innovation. Richard F. Pops, testifying on behalf of the Biotechnology Industry Organization (BIO), praised PDUFA as “common sense recommendations that will help advance innovative new cures for patients.” The praise was not surprising, since BIO and its pharma industry counterpart, Pharmaceutical Research and Manufacturers of America (PhRMA), spent roughly a year in talks with FDA officials to hammer out PDUFA V.

“A fundamental part of biotechnology companies’ ability to innovate and raise private investment is having an FDA with the resources and infrastructure required to review and approve innovative products effectively, consistently, and in a timely manner based on the best available science,” Pops said.

“Unpredictability and inconsistency in the review process, suboptimal communication with sponsors, and decreased FDA performance not only hinders patient access to new treatments but also negatively affects the ability of biotechnology companies to raise funding to support clinical development and ongoing innovation,” Pops added. “This undermines economic growth in the biotechnology sector as well as biomedical research into key public health priorities.”

David E. Wheadon, M.D., PhRMA’s svp, scientific and regulatory affairs, cited a 2011 Battelle report pegging the size of the industry two years earlier as 674,192 direct jobs and a total four million jobs supported in 2009, with an economic output of $918 billion. Those numbers are likely larger today, since the economy was still reeling from the financial market near-collapse of a year earlier and has grown since then, albeit not as robustly as in past recoveries.

“Because PDUFA has injected greater consistency, transparency and predictability into the FDA’s drug review process, its reauthorization is an important factor in ensuring that biopharmaceutical companies maintain this level of job creation and economic growth,” Dr. Wheadon concluded.

For California, the state with the largest biopharma presence, the industry represents about 270,000 direct jobs with salaries averaging $76,000 a year, David L. Gollaher, Ph.D., president and CEO of the California Healthcare Institute, told Congress. “PDUFA V represents the next step in a successful, ongoing partnership between the FDA and industry,” Dr. Gollaher said, and should balance the need to protect public safety “with the importance of continuing robust private-sector investment into new drugs and biologics.

“In the long view, public health and the economic health and competitiveness of the biomedical industry are two sides of the same coin. Without immense investment, the next generation of breakthroughs for our greatest healthcare needs will never materialize. Nor will the jobs to produce them,” Dr. Gollaher pointed out.

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